Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

Study Description

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Brief Summary:

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Candesartan (test); Drug: Felodipine (test); Drug: Candesartan Cilexetil; Drug: Felodipine	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Official Title:	Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
Study Start Date :	October 2008
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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Arm	Intervention/treatment
Single-arm; 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)	Drug: Candesartan (test); 16 mg oral tablet, single dose Drug: Felodipine (test); 5 mg oral extended release tablet, single dose Drug: Candesartan Cilexetil; 16 mg oral tablet, single dose; Other Name: Atacand® Drug: Felodipine; 5 mg oral extended release tablet, single dose; Other Name: Splendil®

Outcome Measures

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Primary Outcome Measures :

1. Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Healthy volunteers
• BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

• Not healthy
• Chronic drug intake

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Brazil
Research Site
Itatiba, SP, Brazil
Research Site
Americana, Brazil

Sponsors and Collaborators

AstraZeneca

Scentryphar Clinical Research

Cori Analyticals

Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C

LabClin Laboratório Clínico

Laboratório de Patologia Clínica Dr. Franceschi Ltda.

Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência

Investigators

Principal Investigator:	Eduardo Abib Junior, MD	Scentryphar Clinical Research
Study Chair:	Moises L. P Vanuncci, MD	Scentryphar Clinical Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00905333 History of Changes
Other Study ID Numbers:	D2452L00021; IMPACT 15381
First Posted:	May 20, 2009
Last Update Posted:	December 7, 2010
Last Verified:	December 2010

Keywords provided by AstraZeneca:

pharmacokinetics; candesartan; felodipine; test formulations; Atacand®	Splendil®; healthy volunteers; blood samples; after meal intake interaction; Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.

Additional relevant MeSH terms:

Candesartan; Candesartan cilexetil; Felodipine; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists	Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Calcium Channel Blockers; Membrane Transport Modulators; Vasodilator Agents